... DUBLIN Ohio Feb. 17 /- Cardinal Health to... Cardinal Health has operated under a consent decree since February... The FDA alleges in the amended consent decree that based on a Janu... We are taking the FDA's observations -- and our obligation to del...

Cardinal Health has operated under a consent decree since February 2007
for its Alaris(R) SE pumps, which resulted in the company implementing a new
quality system on April 2, 2008. Under the amended agreement, which is subject
to approval by the U.S. District Court for the Southern District of
California, Cardinal Health will conduct a thorough review of its broader line
of infusion pump products within 60 days and submit a corrective action plan
to the FDA that outlines all planned modifications to any infusion pump
products. Within 100 days, the company will have an independent expert inspect
and certify whether the company's infusion pump operations are in conformity
with the Quality System Regulation and certain other provisions of the Federal
Food, Drug, and Cosmetic Act. Also within 100 days, the company will have an
independent expert inspect and certify whether its recall procedures and all
ongoing infusion pump recalls are in compliance with the Act and determine
whether additional remedial action should be taken.

The FDA alleges in the amended consent decree that based on a January 2008
inspection, certain Cardinal Health infusion pumps do not satisfy the
standards of the Act. The amended agreement does not impact the company's
ability to market and sell its broader line of infusion pump products, except
for the Alaris SE pump.

"We are taking the FDA's observations -- and our obligation to deliver
safe and effective products -- very seriously," said David Schlotterbeck,
Cardinal Health vice chairman and chief executive officer of Clinical and
Medical Products. "We will continue to improve our systems as we prepare to
meet the additional requirements of the a'/>"/>

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